title: Evidence-based patient information programme in early multiple sclerosis: a randomised controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy of an evidence-based patient information programme aiming to increase informed choice in patients with early multiple sclerosis (MS).
  
  
  BACKGROUND
  Patients with early MS face a number of uncertainties concerning diagnosis, prognosis and effectiveness of immunotherapy. Prior studies suggest that evidence-based patient information combined with group education can promote informed choice in MS patients.
  
  
  METHODS
  A 12-month, six-centre, double-blind randomised controlled clinical trial with 192 patients with a diagnosis of confirmed relapsing-remitting MS or clinical isolated syndrome in Germany. A 4-h interactive evidence-based educational programme was compared with a 4-h MS-specific stress management programme. The primary endpoint was informed choice after 6 months comprising risk knowledge and congruency between attitude towards immunotherapy and actual immunotherapy uptake. Secondary endpoints included autonomy preference, decision autonomy, decisional conflict and satisfaction, anxiety and depression, and number of immunotherapies.
  
  
  RESULTS
  For the primary endpoint, a significant difference was shown with 50 of 85 (59%) participants in the intervention group achieving informed choice after 6 months compared with 18 of 89 (20%) in the control group (OR 0.2 (95% CI 0.1 to 0.4), p<0.001). Four weeks after the intervention, more participants in the intervention group showed good risk knowledge (difference between groups 39% (95% CI 26% to 53%), p<0.001). There were no significant differences between groups for attitude towards immunotherapy and for immunotherapy uptake. There were trends towards increased autonomy preference after the intervention and increased adherence to immunotherapies in the intervention group.
  
  
  CONCLUSIONS
  The intervention significantly increased informed choice and relevant risk knowledge without negative side effects.
authors.affiliation: Institute of Social Medicine, University of Lübeck, , Lübeck, Germany.
authors.forename: Sascha
authors.initials: S
authors.lastname: Köpke
authors.forename: Simone
authors.initials: S
authors.lastname: Kern
authors.forename: Tjalf
authors.initials: T
authors.lastname: Ziemssen
authors.forename: Martin
authors.initials: M
authors.lastname: Berghoff
authors.forename: Ingo
authors.initials: I
authors.lastname: Kleiter
authors.forename: Martin
authors.initials: M
authors.lastname: Marziniak
authors.forename: Friedemann
authors.initials: F
authors.lastname: Paul
authors.forename: Eik
authors.initials: E
authors.lastname: Vettorazzi
authors.forename: Jana
authors.initials: J
authors.lastname: Pöttgen
authors.forename: Korbinian
authors.initials: K
authors.lastname: Fischer
authors.forename: Jürgen
authors.initials: J
authors.lastname: Kasper
authors.forename: Christoph
authors.initials: C
authors.lastname: Heesen
mesh_terms: D000293:Adolescent; D000328:Adult; D003657:Decision Making; D004311:Double-Blind Method; D055317:Evidence-Based Practice / Q000379:methods*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000523:psychology; D010353:Patient Education as Topic
keywords: Multiple Sclerosis